Director of Regulatory Affairs

Cell Therapeutics, Inc. (CTI), a Seattle-based pharmaceutical company, is committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. We strive to do business better than other pharmaceutical companies. Better means a more collaborative, well-trained team environment willing to institute novel approaches to scientific discovery and business opportunities. A willingness to push the limits and achieve challenging goals are the essential attributes that set CTI employees apart.

 

If you feel you have the skills and desire to work in our environment, we currently have the following exciting opportunity available:

 

 

Director of Regulatory Affairs- Job #2008B3NB

This position is responsible for all aspects of the regulatory strategy associated with the Company’s development and commercial products. This includes a primary focus in the United States, as well as supporting European activities.  Additional duties include: ensuring a quality standard for content and format of all communications with the FDA and other Health Authorities and responsibility for the review of regulatory filings as well as coordination with the eSubmission vendors in the format and publication of such submissions.  Will act as liaison for FDA formal and informal contacts.  Requires a Bachelor’s degree or equivalent and 10 years experience within the biotechnology industry and 6 years in Regulatory Affairs.  Prefer experience in all aspects of development, commercialization  - including advertising and promotional activities. Experience with international submissions as well as small molecules is desirable.  Experience developing oncology products is desirable.  Experience with preparation and filing of new drug applications and supplemental drug applications.

 

We offer a competitive compensation and benefits package as well as an environment where your contributions can make a significant difference.  To apply for any of our open positions, please apply online at:

 

http://careers.celltherapeutics.com/

 Please remember to reference Job #2008B3NB

Cell Therapeutics, Inc. (CTI)
Human Resource Development
501 Elliott Avenue W., Ste #400
Seattle, WA 98119
www.cticseattle.com

An Equal Opportunity & Affirmative Action Employer